Exactech, Inc.: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F

Hazard

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Details from the source

Reason for recall: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN Quantity: 1017 devices Lot/code info: a. REF 144-28-05, GUIDID 10885862027405, Serial Numbers: 646995, 646996, 646997, 646998, 667989, 667990, 667992, 667995, 667996, 668002, 668003, 668004, 770434, 770436, 770440, 770442, 770443, 770444, 863939, 863940, 863943, 863944, 863946, 863948, 1242282, 1242283, 1242284, 1242286, 1242287, 1242288, 1242290, 1242291, 1242292, 1617713, 1617715, 1617717, 1617718, 1617719, 1617720, 1617721, 1869774, 1869775, 1869776, 1869777, 1907611, 1907612, 1907613, 1907614, 1961038, 1961039, 1961040, 1961041, 1961042, 2019292, 2019293, 2019294, 2019295, 2174511, 2174512, 2175232, 2314993, 2314995, 2681417, 2681418, 2681428,; b. REF 144-28-06, GUIDID 10885862027412, Serial Numbers: 647081, 647082, 647083, 647084, 647085, 656277, 656278, 656279, 656281, 667456, 667459, 667466, 667467, 667468, 667470, 667471, 667472, 667474, 667475, 667476, 667477, 736674, 736675, 736677, 736678, 736684, 736685, 736687, 736688, 736689, 736691, 736692, 736695, 736697, 736698, 736704, 736705, 736706, 736707, 736710, 736711, 736712, 736716, 736720, 736722, 1088581, 1088582, 1088583, 1088585, 1088586, 1088587, 1088588, 1088589, 1088590, 1088592, 1088593, 1088594, 1088595, 1088596, 1088597, 1088598, 1088599, 1088601, 1088602, 1088604, 1088605, 1088606, 1088607, 1088608, 1088609, 1088611, 1088612, 1088614, 1088615, 1088616, 1088618, 1088619, 1503039, 1503040, 1503041, 1503043, 1613417, 1613418, 1613419, 1613420, 1613421, 1613422, 1613424, 1613425, 1613426, 1613427, 1748075, 1748076, 1748078, 1748082, 1779388, 17793

UPC codes

10885862027405, 10885862027412, 10885862027429, 10885862027436, 10885862027443, 10885862027450, 10885862027719, 10885862027726, 10885862027771, 10885862027467, 10885862027474, 10885862027481, 10885862027498, 10885862027504, 10885862027511

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.